Systemic Effects of Lidocaine Infusion for TAP Block Catheter

NCT ID: NCT03971708

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2020-12-31

Brief Summary

Lidocaine is a local anesthetic that is usually used for nerve blocks to sensory/motor blockade. However, lidocaine can also been given intravenously, and it has been shown that this method can be used to help alleviate chronic pain. We wish to investigate if lidocaine is infused via the transversus abdominis plane (TAP) block catheter will exert systemic effect, hence reduce opioid consumption and pain score in patients compared with using local anesthetic such as ropivacaine.

Detailed Description

Following IRB approval and written consents, patients undergoing nephrectomy were randomized into 2 groups: standard 0.2% ropivacaine infusion (control) and 0.4% lidocaine infusion for TAP catheter. The TAP catheters were placed by the surgeons under direct vision at the end of surgery before wound closure. All subjects had a general anesthetic in accordance to the discretion of the anesthesiologist in the operating room. At the end of surgery, all patients received a patient-controlled analgesia (PCA) in recovery for 48 hours. The primary outcome was the total opioid consumption at the first 27 hours post-operatively. The secondary outcomes were the total opioid consumption at 4/12/24/36/48/60 hours after the initiation of local anesthetic infusion, the numerical rating scale (NRS) at rest and on movement at 4/12/24/36/48/60 hours after the initiation of the local anesthetic infusion, the incidence of nausea and vomiting, and adverse effects.

The sample size calculation for this non-inferiority trial is based on our previous retrospective study on TAP in nephrectomy patients. A sample of 80 patients is needed, using a power of 90% with the two-sided significance level of 5%. All parametric data will be analyzed using mean and standard deviation. Non-parametric data will be analyzed using median and interquartile range. Student's t-test or Mann-Whitney U test will be used to compare between groups.

Conditions

Nephrectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ropivacaine

This is the control where patients will receive ropivacaine via the TAP block infusion post-operatively.

Group Type: OTHER

Ropivacaine

Intervention Type: DRUG

Local anesthetic

Lidocaine

This is the study arm where patients will receive lidocaine via the TAP block infusion post-operatively.

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

Local anesthetic

Interventions

Lidocaine

Local anesthetic

Intervention Type: DRUG

Ropivacaine

Local anesthetic

Intervention Type: DRUG

Other Intervention Names

Lignocaine

Eligibility Criteria

Inclusion Criteria

• Elective nephrectomy
• patients consent to study
• ASA I to III

Exclusion Criteria

• Patient refusal
• Allergy to lidocaine,
• Patients with cardiac arrhythmias or on anti-arrhythmics or propranolol
• Wolf-Parkinson White syndrome
• Hepatic disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

Pro00054477

Identifier Type: -

Identifier Source: org_study_id